Randomized, Double-Masked, Sham-Controlled Trial of Ranibizumab for Neovascular Age-related Macular Degeneration: PIER Study Year 1

To evaluate the efficacy and safety of ranibizumab administered monthly for three months and then quarterly in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Phase IIIb, multicenter, randomized, double-masked, sham injection-controlled...

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Vydáno v:American journal of ophthalmology Ročník 145; číslo 2; s. 239 - 248.e5
Hlavní autoři: Regillo, Carl D., Brown, David M., Abraham, Prema, Yue, Huibin, Ianchulev, Tsontcho, Schneider, Susan, Shams, Naveed
Médium: Journal Article
Jazyk:angličtina
Vydáno: New York, NY Elsevier Inc 01.02.2008
Elsevier
Elsevier Limited
Témata:
Aged
Aged, 80 and over
Angiogenesis Inhibitors - administration & dosage
Angiogenesis Inhibitors - adverse effects
Antibodies, Monoclonal - administration & dosage
Antibodies, Monoclonal - adverse effects
Antibodies, Monoclonal, Humanized
Biological and medical sciences
Choroidal Neovascularization - drug therapy
Choroidal Neovascularization - etiology
Diabetic retinopathy
Double-Blind Method
Drug dosages
Female
Humans
Injections
Macular degeneration
Macular Degeneration - complications
Macular Degeneration - drug therapy
Male
Medical sciences
Middle Aged
Miscellaneous
Occult sciences
Ophthalmology
Ranibizumab
Retinopathies
Treatment Outcome
Visual Acuity - drug effects
Vitreous Body
Retinopathy
Mask
Monoclonal antibody
Macular degeneration
Immunomodulator
Eye disease
Vascular endothelium growth factor
Ranibizumab
Clinical trial
Age related macular degeneration
Neovascularization
Ophthalmology
Antiangiogenic agent
ISSN:0002-9394, 1879-1891
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Popis
Shrnutí:To evaluate the efficacy and safety of ranibizumab administered monthly for three months and then quarterly in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Phase IIIb, multicenter, randomized, double-masked, sham injection-controlled trial in patients with predominantly or minimally classic or occult with no classic CNV lesions. Patients were randomized 1:1:1 to 0.3 mg ranibizumab (n = 60), 0.5 mg ranibizumab (n = 61), or sham (n = 63) treatment groups. The primary efficacy endpoint was mean change from baseline visual acuity (VA) at month 12. Mean changes from baseline VA at 12 months were −16.3, −1.6, and −0.2 letters for the sham, 0.3 mg, and 0.5 mg groups, respectively ( P ≤ .0001, each ranibizumab dose vs sham). Ranibizumab arrested CNV growth and reduced leakage from CNV. However, the treatment effect declined in the ranibizumab groups during quarterly dosing (e.g., at three months the mean changes from baseline VA had been gains of 2.9 and 4.3 letters for the 0.3 mg and 0.5 mg doses, respectively). Results of subgroups analyses of mean change from baseline VA at 12 months by baseline age, VA, and lesion characteristics were consistent with the overall results. Few serious ocular or nonocular adverse events occurred in any group. Ranibizumab administered monthly for three months and then quarterly provided significant VA benefit to patients with AMD-related subfoveal CNV and was well tolerated. The incidence of serious ocular or nonocular adverse events was low.
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ISSN:0002-9394
1879-1891
DOI:10.1016/j.ajo.2007.10.004